Senior CRA in Stirling, Scotland
Brandon Whates is recruiting for a Senior CRA to join a dynamic diagnostics company developing breakthrough medical devices on a full time, permanent basis. They are looking for an experienced Clinical Research Associate who can make a significant contribution to the continued growth and success of the company.
These positions are based in the historic market town of Stirling, Scotland. Known as the “Gateway to the Highlands”, Stirling is steeped in exciting medieval history, with Stirling Castle and the Wallace Monument overlooking the region. It is situated close to the wild beauty of Loch Lomond & The Trossachs National Park.
Key Responsibilities: Technical:
- Technical lead for ensuring the clinical trial study design meets the needs of the product launch plan.
- Identify appropriate clinical sites and manage effective clinical relationships. Liaise with the Principal Investigator and clinical operations staff as required.
- Organise/prepare/attend investigator meetings as required.
- Prepare, edit, review and submit clinical documentation.
- Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required e.g IRAS, HRA and R&D submissions.
- Management of clinical sites to ensure protocol, source data verification and CRF compliance.
- Lead pre-study initiation, interim monitoring and close out visits as required.
- Prepare, monitor and report clinical study budgets.
- Provide continuous up-date of trial status to relevant key stakeholders, identifying potential delays that may impact product launch.
Communication & Liaison:
- Establish and manage effective clinical and/or supplier relationships.
- Understand the relevant clinical requirements; liaise with cross functional team leaders to provide robust clinical outcomes.
- Excellent communication skills, especially written and verbal to ensure all key stakeholders are kept current and effective relationships (both internally and externally) are built.
- May have line management responsibility for junior staff.
- Train others, internally and externally in areas of expertise.
- A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or in-depth experience in performing a Clinical Research Associate role preferably with Medical Devices or In Vitro Medical Devices.
- Work experience within either a hospital, medical/research centre environment, Contract Research Organisation or Pharmaceutical company.
- Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.
- Ability to independently create and drive the development of clinical trial related documents and materials.
- Ability to independently perform pre-study initiation, interim monitoring and close out visits as required.
- Ability to mentor, train, supervise and support junior members of the team.
- Excellent communication skills, including the ability to present complex information to both clinical and non-clinical disciplines.
- Computer Literate.
- Receptive to working in a fast-paced, constantly changing work environment.
- Knowledge of statistics.
- Knowledge of FDA regulatory requirements.
- Experience across a wide range of clinical indications/therapeutic areas.
For more information or to apply for this position, please contact Brandon Whates on 01438 768715 or email firstname.lastname@example.org. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained. CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44445 in all correspondence.